这个注射药物多紧缺？可以允许用户自己检查过滤

一沙一叶

                            这个注射药物多紧缺？可以允许用户自己检查过滤

这两天ECA转载了一个新闻：
题目是：Visual Control by Doctor and Patient?医生和病人目视控制（注射剂颗粒）
大致内容：  Jazz工厂生产的冻干注射剂可能含有可见颗粒，为了确保药物供应，需要在注射前进行目视检查并且还要增加一道5µm的滤器进行过滤。
            Bundesamt für Arzneimittel in Germany (BfArm)声明说，对于179和180批次检查发现，塞子上有颗粒，可能冻干产品本身也有。但是为了保证市场供应，一些产品已经放行， 并通知大家产品需要用5µm的滤器进行过滤。
            Jazz工厂的人说，在溶解之前要看看颗粒是只出现在塞子上，还是在产品本身上也有。
            消息上说颗粒原因可能是由于玻璃层离。

事件本身的信息并不多。
但是，可以确定的是这是不符合GMP要求的，因为无论是EMA，FDA，保证产品质量都是生产商的职责。
虽然，JAzz厂家声称这些颗粒以及过滤不会对质量产生影响，但是采取这样的临时措施，对病人的风险如何呢？
病人和医生是否有能力识别颗粒（在塞子上？在药品中？）？是否有条件有能力进行过滤的无菌操作？
如何对这类稀缺药供应商进行管理？难道GMP法规可以弹性执行？




Visual Control by Doctor and Patient?To avoid supply bottlenecks, batches of lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer. The Bundesamt für Arzneimittel in Germany (BfArm) states that an inspection of lots 179 and 180 revealed particulates on the plugs and possibly the lyophilisate itself. The affected vials had been sorted out. To ensure market supply however, several bottles have been released now with the notice that the content is to be filtrated with a 5 µm filter needle.
According to the manufacturer Jazz Pharmaceuticals, it is to be examined before reconstitution whether the particulates only appear on the underside of the plugs and not the lyophilisate, i.e. the product itself.
The reconstituted solution should be free of particulates; a subsequent filtration is to make sure of that. According to the manufacturer, the additional filtration does not affect the product's quality.
That is interesting considering that in a Q&A document, the European Medicines Agency rules out filtration as a procedure for particle removal ("Particles originated from the container closure system"). The example above is about particulates due to glass delamination and the routine addition of filtration to the instruction leaflet. According to the EMA, it shouldn't be the patient's task to ensure the quality of a product; this is the manufacturers' duty. The difference is that in the case of Jazz Pharmaceuticals the described measures are only temporary and not for routine.

flash02

物殊情况，不用药死人，用了不一定死，你选哪一个的问题。

孙艳红

急救药品？不可替代！

xqliu

那以后出了问题就是医生和患者的了。

werewolfman

有点意思。